Poor Ovarian ResponseNCT07282288
A RCT Study on Autologous Cell Injection Into the Ovaries of Patients With POR
A study testing PRP injection and SVF injection in people with Poor Ovarian Response, run by Peking University Third Hospital.
Trial summary
Poor ovarian response (POR) is a pathological state where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a small number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a low number of retrieved oocytes, and a low clinical pregnancy… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Poor Ovarian Response
- What is being tested?
- PRP injection and SVF injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who have fertility requirements and are seeking IVF treatment
- Age ≤ 45 years old, infertility duration ≥ 1 year
- Meeting the diagnostic criteria for POI or the Poseidon diagnostic criteria for POR
- Previous controlled ovarian stimulation resulted in no more than 3 oocytes retrieved and/or no transplantable embryos and/or previous embryo implantation failure ≥ 2 times
- Uterus and bilateral adnexa are intact
- BMI 22 - 29 kg/m²
- Participants must have given informed consent for this study and voluntarily signed a written informed consent form.
Who cannot join
- Congenital abnormalities of reproductive organs
- Septicemia, platelet dysfunction syndrome and severe thrombocytopenia and other coagulation disorders or other hematological diseases
- Suffering from autoimmune diseases or other endocrine disorders, with abnormal thyroid function and uncontrolled condition
- Having a mass in the adnexal area with an unclear benign or malignant nature
- Complicated with severe cardiovascular and cerebrovascular diseases, malignant tumors, hematological diseases and mental disorders, patients with impaired function of important organs
- Those who have used systemic corticosteroids within the last 2 weeks, or used antiplatelet drugs such as aspirin within the last 48 hours
- In the acute inflammatory stage
- Those with a history of venous thrombosis or pulmonary embolism during the screening period
About this study
Official title: A Randomized Controlled Study on Autologous Cell Injection Into the Ovaries of Patients With Poor Ovarian Response
Poor ovarian response (POR) is a pathological state where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a small number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a low number of retrieved oocytes, and a low clinical pregnancy rate. Premature ovarian insufficiency (POI) is a special type of this condition and is one of the most difficult infertility diseases to treat. The incidence of POR and POI in reproductive-aged women in China is increasing year by year, making them key and challenging issues in reproductive medicine. New local ovarian cell therapy can improve the microenvironment for follicle development, promote the development and ovulation of "dormant" primordial follicles, and improve the quality of oocytes. This study intends to conduct autologous fat vascular matrix components (SVF) or autologous platelet-rich plasma (PRP) local injection therapy for patients with POR and POI, and conduct a prospective exploratory study to evaluate the safety of this clinical technique. Subsequently, a prospective randomized controlled trial will be conducted to evaluate the safety and efficacy of autologous fat vascular matrix components (SVF) or autologous platelet-rich plasma (PRP) local injection therapy in improving ovarian reserve and IVF-ET outcomes. This study is expected to improve the fertility of patients with POR from the perspective of autologous cell therapy. The autologous SVF and PRP local injection techniques do not involve ethical barriers, are easy to standardize the diagnosis and treatment process and operation system, and are suitable for clinical translation and promotion.
- Conditions
- Poor Ovarian Response
- Being tested
- PRP injection, SVF injection
- Keywords
- Poor ovarian response, Premature ovarian insufficiency, autologous fat vascular matrix components, autologous platelet-rich plasma
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionOther
Injecting PRP into the ovaries
SVF injectionOther
Injecting SVF into the ovaries
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | Not described Receives: Other: PRP injection |
| SVF group | Experimental | Not described Receives: Other: SVF injection |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved oocytes
Measured: 6month
Secondary outcomes (3)
anti-Müllerian hormone level
Measured: 6 month
Number of antral follicles
Measured: 6 month
clinical pregnancy rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Ovarian ResponseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Caihong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282288
- Sponsor's protocol ID
- IRB00006761-M20250882
- Other IDs
- BRWEP2024W094090102
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on Autologous Cell Injection Into the Ovaries of Patients With Poor Ovarian Response
- ClinicalTrials.gov ID
- NCT07282288
- Acronym / sponsor ID
- IRB00006761-M20250882
- Conditions
- Poor Ovarian Response
- Keywords
- Poor ovarian response, Premature ovarian insufficiency, autologous fat vascular matrix components, autologous platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Poor ovarian response (POR) is a pathological state where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a small number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a low number of retrieved oocytes, and a low clinical pregnancy rate. Premature ovarian insufficiency (POI) is a special type of this condition and is one of the most difficult infertility diseases to treat. The incidence of POR and POI in reproductive-aged women in China is increasing year by year, making them key and challenging issues in reproductive medicine. New local ovarian cell therapy can improve the microenvironment for follicle development, promote the development and ovulation of "dormant" primordial follicles, and improve the quality of oocytes. This study intends to conduct autologous fat vascular matrix components (SVF) or autologous platelet-rich plasma (PRP) local injection therapy for patients with POR and POI, and conduct a prospective exploratory study to evaluate the safety of this clinical technique. Subsequently, a prospective randomized controlled trial will be conducted to evaluate the safety and efficacy of autologous fat vascular matrix components (SVF) or autologous platelet-rich plasma (PRP) local injection therapy in improving ovarian reserve and IVF-ET outcomes. This study is expected to improve the fertility of patients with POR from the perspective of autologous cell therapy. The autologous SVF and PRP local injection techniques do not involve ethical barriers, are easy to standardize the diagnosis and treatment process and operation system, and are suitable for clinical translation and promotion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Other: PRP injection |
| SVF group | Experimental | Other: SVF injection |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women who have fertility requirements and are seeking IVF treatment
- Age ≤ 45 years old, infertility duration ≥ 1 year
- Meeting the diagnostic criteria for POI or the Poseidon diagnostic criteria for POR
- Previous controlled ovarian stimulation resulted in no more than 3 oocytes retrieved and/or no transplantable embryos and/or previous embryo implantation failure ≥ 2 times
- Uterus and bilateral adnexa are intact
Key exclusion criteria (8 listed)
- Congenital abnormalities of reproductive organs
- Septicemia, platelet dysfunction syndrome and severe thrombocytopenia and other coagulation disorders or other hematological diseases
- Suffering from autoimmune diseases or other endocrine disorders, with abnormal thyroid function and uncontrolled condition
- Having a mass in the adnexal area with an unclear benign or malignant nature
- Complicated with severe cardiovascular and cerebrovascular diseases, malignant tumors, hematological diseases and mental disorders, patients with impaired function of important organs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP injectionInjecting PRP into the ovaries | Other | PRP group |
| SVF injectionInjecting SVF into the ovaries | Other | SVF group |
Primary outcome
Number of retrieved oocytes
Time frame: 6month
3 secondary outcomes
anti-Müllerian hormone level
Time frame: 6 month
Number of antral follicles
Time frame: 6 month
clinical pregnancy rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection and SVF injection in people with Poor Ovarian Response, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrieved oocytes (time frame: 6month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.